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Device makers have been scrambling for space in value-based care arrangements even though the pace of adoption of those arrangements has been somewhat tepid. While device makers are not explicitly included in a proposed overhaul of the Stark and Anti-Kickback Statute (AKS) regulations, providers may soon be more engaged in these arrangements, thus providing device makers with more opportunities even if they are not included in the rewrite of the related regulatory provisions.
Those who believe the U.S. Supreme Court must revisit the patent subject matter eligibility problem may get their wish. While Solicitor General Noel Francisco advised the Court that it should not hear the Berkheimer case, he nonetheless said that Athena v. Mayo might avail the Supreme Court of the appropriate fodder for resolving the ongoing subject matter eligibility problem.
The U.S. Senate voted 72-18 to confirm Stephen Hahn as the commissioner of the FDA, providing the agency with another commissioner with a deep background in oncology. Hahn succeeds Scott Gottlieb, who stepped down from the post in April and returned to the American Enterprise Institute.
The FDA has lost a product jurisdiction case in DC district court to Genus Medical Technologies LLC over its barium sulfate contrast agent. The judge in the case ruled that the agency violated the Administrative Procedures Act in ruling that the product is a drug, but the FDA will have another crack at the matter as the application for the product has been remanded to the FDA.
The U.S. Environmental Protection Agency (EPA) has posted an advanced notice of proposed rulemaking for control of ethylene oxide emissions (EtO), which would update a 2006 final rule that declared no additional controls for EtO were necessary. However, the agency’s latest proposed rule makes note of several technological advances that allow for greater control of EtO, a fact that could drive a greater regulatory requirement for containment and destruction of EtO emissions at medical device sterilization plants.
Policymakers are often as sensitive to overall health care spending as they are to increases in Medicare spending, and the latest report on both brought some good news and some bad news. The good news is that overall health care spending was essentially flat as a share of gross domestic product (GDP) in 2018, but the bad news is that Medicare spending jumped 6.4%, thus renewing the troublesome historical trend of outpacing typical GDP growth.
The Watchman left atrial appendage device, distributed by Marlborough, Mass.-based Boston Scientific Corp., holds a unique place in the annals of med tech regulation, but 50-month data from two registries show a lower rate of hemorrhagic stroke than previously reported for the device.
The patent lawsuit of Athena v. Mayo revisits previous case law where patent subject matter eligibility is concerned, and numerous parties have weighed in urging the Supreme Court to hear the case. However, the U.S. Solicitor General has not responded with its own friend-of-the-court brief, an omission that would seem to take some of the pressure off the Supreme Court to hear the case.
The impending resumption of the 2.3% tax on medical devices has industry actively seeking at least a new suspension. Now, the Tax Foundation, of Washington, has issued a report saying that the tax would cost more than 21,000 Americans their jobs and impose a $1.7 billion hit on the U.S. economy.
The U.S. FDA has cleared Cochlear Ltd.’s newest cochlear implant, the Osia 2 system, an active implantable bone conduction hearing system. Unlike Cochlear’s...
LONDON – It’s no secret that American citizens pay the most for drugs, but the extent of the disparity is laid bare in a new index of the prices of 13 medicines...
Commissioner of the FDA for five years starting in 1984, Frank Young relished his position “at the vortex of controversy” as he sought to deal with the AIDS...
After being in the doldrums for the majority of the year, public biopharmaceutical companies, it appears, have turned the corner and are now on a major upswing.
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